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Like many Latin American countries, Colombia and the Dominican Republic grapple with the financial burden of covering high-cost medicines (HCMs). While some of these drugs are highly effective, others have reduced clinical effectiveness. Each of these drugs carries an opportunity cost in terms of the health gains lost by allocating these resources elsewhere. We quantified the health opportunity cost of funding HCMs in Colombia and the Dominican Republic.
Methods
An identification strategy for HCMs was employed in both countries, based on their significant budgetary impact or high cost per case. This resulted in a shortlist of 10 molecules for Colombia and another 10 for the Dominican Republic. The health opportunity costs were estimated using the standard methodology of net health benefit, with the country-specific cost-effectiveness threshold employed as a proxy for average health production per dollar invested in the health systems of the two cases under study.
Results
The selected HCMs included drugs for cancer, rare diseases, diabetes, and multiple sclerosis. The incremental health gains provided by these drugs were less than two life years in perfect health. In Colombia, funding the analyzed HCMs instead of the best available therapeutic alternatives implied an additional cost of USD642 million for the treatment of 22,155 covered patients. If these resources were allocated to expand services available within the system, the net gain would be 122,507 quality-adjusted life years (QALYs). In the Dominican Republic, the additional cost was estimated to be USD154 million (14,577 patients), with an estimated opportunity cost of 35,221 QALYs.
Conclusions
The significant health opportunity costs for two countries with gaps in essential health services highlight the need for policies prioritizing efficient spending. Redirecting resources from the analyzed HCMs to cost-effective essential services could enhance health gains, addressing coverage gaps and advancing progress toward universal health coverage.
Existential distress is a debilitating condition in end-of-life cancer patients. The Psycho-existential Symptom Assessment Scale (PeSAS) was developed to screen psycho-existential symptoms in palliative care, but limited research has examined its use. This study aimed to implement the Italian version of the PeSAS in palliative care services and to evaluate changes in healthcare providers’ (HCPs) competence after experiential training. It also aimed to estimate the frequency of psycho-existential symptoms and explore the scale structure using network analysis.
Methods
Two-hour experiential workshops were conducted in 5 Italian palliative care services by a clinical psychologist specialized in psycho-oncology and palliative care. Training covered psycho-existential distress, role-play, and feedback. Pre- and post-workshop questionnaires assessed clinicians’ self-efficacy in evaluating physical, psycho-existential, and suicidal symptoms, managing distress, and providing psychosocial support. Patient cross-sectional data were analyzed with descriptive statistics, t-tests, chi-square tests, and exploratory graph analysis.
Results
One hundred one clinicians from 3 services participated. Significant results were found in HCPs’ self-efficacy, with the largest effect in assessing suicidal symptoms (Cohen’s d = 0.54), followed by managing distress (d = 0.47) and evaluating psycho-existential symptoms (d = 0.40). Of 210 patients screened, 194 were included. PeSAS scores were strongly associated with Hopelessness (strength = 1.30) and depression (1.18), while being trapped by illness (−1.64) and wishing to die (−1.12) had weaker associations.
Significance of results
The Italian PeSAS is feasible for integration into palliative care. Strong associations highlight targets for interventions, while weaker associations suggest the need for additional approaches. PeSAS enhances HCPs’ ability to address the psycho-existential needs in end-of-life care.
The Health Information and Quality Authority (HIQA) Health Technology Assessment (HTA) Directorate, established in 2007, has rapidly expanded to more than 50 personnel working across seven teams. This expansion requires significant support for HTA activities, particularly in light of ongoing work to support implementation of the European Union Regulation on HTA. This abstract describes the impact of a recently established support function within the Directorate.
Methods
The Strategy, Support, and Research (SSR) team was established in May 2023 to support HTA Directorate project delivery. The SSR team currently includes a Senior Management Team Lead, a Senior HTA Program Manager, a Librarian, and a Program Administrator. Specifically, the SSR team provides program management, administration, librarian support, corporate reporting, placement coordination, and risk management services, and supports research, learning and development, and quality improvement initiatives.
Results
In 2024, the SSR team facilitated HTA activities by coordinating administration, project management, and librarian support for 16 projects, including 15 meetings with expert advisory groups comprising 285 key stakeholders. Twelve literature searches were conducted and 17 reports were published. Two Impact assessment reports were produced, which have 83 downloads and 3,217 social media impressions. The SSR team supported competitive grant funding applications securing more than EUR2.56 million in research funding, successfully applied for tenders with European HTA partners, and supported HIQA to successfully attain ISO 9001:2015 accreditation. This work supports outputs which inform health policy and decision-making in the healthcare ecosystem.
Conclusions
With the increasing demand on HTA agencies, it is imperative that there is an effective support system in place to ensure that high quality outputs are delivered and stakeholders’ needs are met. The establishment of the SSR team in the HIQA HTA Directorate provides an example of how a dedicated team can provide support and impact for an expanding HTA agency.
Adapting health technology assessment (HTA) reports developed by other institutions is efficient to avoid duplication of effort, foster collaboration and knowledge exchange internationally, and improve efficiency. Similar challenges can be faced by institutions who can benefit from experience sharing. A tool for adapting HTA reports in the Americas region was proposed by the Health Technology Assessment Network of the Americas (RedETSA).
Methods
The RedETSA adaptation tool was developed by the RedETSA Working Group on Adaptation of HTA Reports with the participation of 14 people from different countries in the region. To develop this tool, the EUnetHTA tool—translated to Spanish and adapted by the Working Group of the Rapid Reporting Guide for HTA of the Spanish Network of Agencies for HTA and Services of the National Health System (RedETS)—was used as a basis. An iterative process of review, design, and decision was conducted by the entire RedETSA Working Group to develop and finalize the RedETSA tool.
Results
The proposed procedure for adapting reports includes two stages: (i) identification of HTA reports to adapt using different search engines; and (ii) evaluation of the HTA report for adaptation. The proposed tool for evaluating the report to adapt includes a set of questions organized around three modules: module one is a rapid screening on initial operational aspects of the report; module two questions the quality of the report, including the use of technology in the context of the report, efficacy, effectiveness, and safety domains; and module three reviews the feasibility of its application to the local context.
Conclusions
Adapting HTA reports promotes inter-country cooperation, strengthens technical capacities, and avoids duplication of effort. A variety of aspects determines whether a report is suitable or not for adaptation. This proposed tool should be considered as a support guide, subject to local criteria in decision-making, and not a quantitative tool with prescriptive cut-off points.
Horizon scanning is a methodology used to identify signals and insights that serve as early awareness indicators. We present a free web application that houses the National Institute for Health and Care Research (NIHR) Innovation Observatory’s data dictionary, allowing users to generate a data extraction template and provide search source suggestions. This resource aims to build capacity in horizon scanning by promoting knowledge exchange and improving productivity.
Methods
We identified core data extraction points from four years of horizon scans (n=20). These were divided into 11 categories and linked to scan type, time horizon, and potential search sources. We used Microsoft Access to create a relational database, later converted to SQLite. Python and Streamlit were used to develop a front-end web application. The tool enables users to select parameters relevant to their horizon scan needs and generates customized data extraction templates and search source suggestions. Eight data points specific to the NIHR Innovation Observatory were included in the data dictionary but excluded from the template generator.
Results
The web application incorporates 148 data points linked to nine types of horizon scans, three scan categories, three time horizons, and 183 search sources. Users can generate tailored data extraction templates based on selected criteria, facilitating a structured approach to horizon scanning. The tool’s features include an intuitive interface, customizable templates, and comprehensive search source recommendations. While formal evaluation is planned, initial internal feedback indicated the tool effectively reduces time on tasks and improves productivity. Future updates will focus on incorporating user feedback and enhancing functionality.
Conclusions
This free-to-access resource provides a starting point for anyone wanting to conduct a horizon scan. It offers a comprehensive data dictionary, promotes knowledge exchange and transparency, and allows users to generate robust and reproducible data extraction templates. Plans are underway to formally evaluate the tool’s effectiveness and gather user feedback to inform future updates.
Since 2012, all drugs dispensed in the Brazilian Unified Health System (SUS) must be incorporated by the National Committee for Health Technology Incorporation (CONITEC). However, the characteristics of budget impact analyses (BIA) of incorporated drugs for chronic degenerative and rare diseases are unclear. Thus, our aim was to identify the profile of BIA of these drugs in the SUS between 2012 and 2024.
Methods
Based on the 2012 to 2024 public reports of the CONITEC, data were collected on proposals for the incorporation of drugs for chronic degenerative and rare diseases into the SUS. The proposals were categorized by the type of incorporation proponent (public or private) and disease (rare or other chronic), by the presence of BIA, and by adoption of measured demand and active comparator. In addition, the median values of the eligible population and market share (first and fifth years) were calculated.
Results
Among the 153 incorporated drugs, 53.6 percent (n=82) were proposed by private institutions, 36.6 percent (n=56) were for rare diseases, and 69.3 percent (n=106) presented a budget impact analysis. Among all BIA, 68.7 percent (n=79) adopted measured demand, frequently in other chronic diseases (76.1% [n=51] versus 58.3% [n=28]), and 25.0% (n=29) had no active comparator, more often in rare diseases (41.7% [n=20] versus 13.2% [n=9]). The median of the estimated population was higher for the other chronic diseases (27,237 versus 1,550). The median market share values were higher for rare diseases in both the first and fifth years (41.3% and 70.0% versus 20.0% and 50.0%).
Conclusions
Most of the proposals presented BIA. The BIA for rare diseases used measured demand less frequently, had fewer active comparators, and smaller population medians, which may justify the higher market share rates. Since drugs for chronic degenerative and rare diseases are often high cost, knowing the profile of BIA is essential to improve CONITEC’s decision-making and to ensure the sustainability of the SUS.
Health technology assessment (HTA) is essential for informed, transparent, and efficient resource allocation in Mexico’s health system. Despite efforts by institutions like the General Health Council and the National Center for Health Technology Excellence (CENETEC), formal prioritization methods are lacking. This study aimed to develop a prioritization framework, based on the EVIDEM model, via a Delphi panel, integrating clinical, economic, ethical, and social criteria to enhance decision-making.
Methods
Conducted between May and December 2024, this project was initiated by the Interinstitutional HTA Working Group to develop a preliminary multi-criteria decision analysis (MCDA) framework for prioritizing health technologies in Mexico. Phases included a systematic literature review, the formation of a multidisciplinary expert panel, and consensus rounds to select key criteria based on the EVIDEM model, ensuring non-redundancy and independence. The process and results were documented in a manuscript for publication in 2025, aiming to strengthen decision-making in Mexico’s health system.
Results
In the first phase, 10 key studies were identified through a comprehensive search protocol, 60 percent of which utilized MCDA for prioritization. These studies averaged 19 relevant criteria, many of which were aligned with the EVIDEM framework, negating the need for new criteria. In the second phase, a multidisciplinary panel of 20 experts from key Mexican public health institutions was formed. Through two consensus rounds in the third phase, 10 of 25 fundamental criteria were selected, including disease severity, comparative effectiveness, costs, and evidence quality. Notably, 80 percent of the selected criteria aligned with the core EVIDEM model.
Conclusions
The proposed MCDA framework marks an initial step toward a structured tool for prioritizing health technologies in Mexico. While validation is needed to confirm its applicability, implementation of the framework has the potential to optimize equitable, criteria-based decision-making, benefiting both the health system and the population.
Influenza is an acute infectious disease that is highly transmissible and affects the respiratory system. It impacts the health system and society by reducing a patient’s productivity and quality of life. The population group most susceptible to complications and death is adults older than 65 years and children younger than five years.
Methods
The analysis was performed from the perspective of the Unified Health System (SUS) as the funder. The eligible population was estimated based on epidemiological data from population projections by the Brazilian Institute of Geography and Statistics for a five-year time horizon. The assumption of 90 percent vaccination coverage was adopted as market share. Analyses were performed by scenarios that varied market share and added costs with clinical benefits. Costs were estimated on a national basis, considering the price of the technology, inputs, and waste. Hospitalization costs and their confidence intervals were obtained from the SUS Hospitalization Authorization database.
Results
The cost of vaccination with the high-dose trivalent influenza vaccine was estimated at USD119,637,999.04 in the first year and USD657,405,529.68 over a five-year time horizon. The increase in the budget was USD104,034,983.12 in the first year and USD571,747,563.22 over five years. The alternative scenario one was estimated considering vaccination coverage in 2023 of 63.3 percent, obtaining an incremental impact of USD72,824,488.19 in the first year and USD400,167,351.63 in five years. Alternative scenario two considered the reduction in hospitalizations and found an incremental impact of USD103,908,194.74 in the first year and USD570,970,948.59 in five years.
Conclusions
The budgetary impact was estimated at over USD571 million in five years. In absolute numbers, the reduction in hospitalizations due to influenza (0.4%) and pneumonia (0.3%) was not very significant, which generated a reduction in the incremental budgetary impact, in relation to the main scenario of the analysis, of 0.02 percent in the first year and 0.13 percent in five years.
Paroxysmal nocturnal hemoglobinuria (PNH) is a rare and life-threatening blood disorder, affecting one to 1.5 new individuals per million annually worldwide. In Brazil, there are three registered treatments: eculizumab, pegcetacoplan, and ravulizumab, while crovalimab is currently under evaluation by ANVISA, the Brazilian Health Regulatory Agency. This study examined the impact of these PNH treatments on the logistics and time required by healthcare professionals and patients for administration.
Methods
Quantitative and descriptive analysis was conducted based on information from the package leaflets of eculizumab, ravulizumab, pegcetacoplan, and crovalimab regarding the number of vials, volume, and administration time for each medication for a patient with PNH weighing between 60 and 100 kg over a period of 52 weeks.
Results
The number of vials required for treatment over 52 weeks was 78 for eculizumab, 102 for pegcetacoplan, 70 for ravulizumab, and 26 for crovalimab. The volume to be transported would be 4,680 mL for eculizumab, 2,080 mL for pegcetacoplan, 231 mL for ravulizumab, and 52 mL for crovalimab. Regarding the time required for each infusion per year (52 weeks), it would take 14.6 hours for eculizumab, 4.7 hours for ravulizumab, 78 hours for pegcetacoplan, and 1.1 hours for crovalimab.
Conclusions
This study demonstrated that crovalimab can reduce the number of vials needed by 169 percent, transportation and storage volume by 344 percent, and infusion time by 331 percent. These efficiencies, applicable to both healthcare professionals and patients, highlight crovalimab’s potential to significantly enhance the sustainability of Brazilian public healthcare system and improve quality of life for patients.
The primary objective of the Handbook of EBPP is to empower professionals, researchers, students, and the public with the skills needed to read and critically interpret biomedical literature relevant to psychology. By fostering a deeper understanding of evidence-based approaches, the Handbook aims to enhance the quality and effectiveness of mental health services, ultimately improving care outcomes.
Methods
The Handbook is systematically organized into three main sections.
• Foundations: This section explores the conceptual and historical development of EBPP, establishing its relevance and importance within psychological practice.
• Methodology: Detailed guidance is provided on essential methodological tools, such as framing research questions with the PICO (population, intervention, comparator, outcome) model, navigating electronic databases effectively, and critically analyzing scientific literature. Emphasis is placed on the role of experimental designs, systematic reviews, and meta-analyses in evidence-based practice.
• Interventions: The third section focuses on the efficacy, effectiveness, and safety of psychosocial interventions, highlighting their critical role in the prevention and treatment of mental health disorders.
Results
Although quantitative assessments of the Handbook’s impact are not included in this abstract, its comprehensive approach addresses a crucial gap in the Portuguese-speaking mental health community. By presenting accessible, scientifically validated practices, it establishes itself as a cornerstone for evidence-based psychological education and care.
Conclusions
The Handbook of EBPP meets an urgent demand for Portuguese-language educational materials on evidence-based psychology. Adhering to the principles of the Cochrane Collaboration, it ensures that clinical guidelines are transparent, rigorously evaluated, and regularly updated. This resource is a significant step forward for the professionalization of psychological practice in Brazil, advancing ethical, evidence-based care and improving individual mental health outcomes.
Breast cancer (BC) confers a high burden on the Brazilian population. Moreover, the possible overuse of adjuvant chemotherapy in patients with a low risk of tumor recurrence may subject these individuals to harmful side effects, without offering substantial therapeutic advantages. The implementation of genomic testing for risk stratification represents a promising strategy to optimize patient care.
Methods
We assessed the economic implications of integrating the Oncotype DX Breast Recurrence Score Test® for stratifying BC patients according to their recurrence score (RS). A decision tree and Markov model estimated the long-term costs and outcomes linked to transitions between the health states of recurrence-free, distant recurrence, acute myeloid leukemia, and death. Patient distributions and probabilities of distant recurrence were obtained from the TAILORx (N0) and RxPONDER (N1) clinical trials. Local evidence on utility and overall survival was also considered. The analysis was carried out from the perspective of the Brazilian private healthcare system. Deterministic and sensitivity analyses were conducted.
Results
Compared with clinical and pathological risk alone, adding the Oncotype DX test for all BC patients (N0 or N1) generated more quality-adjusted life years (QALYs) at lower costs (0.15 QALYs and −USD41,251.80). The three most efficient indications included: restricted to N1 (0.28 QALYs and −USD6,032.65); N0 restricted to high risk and N1 restricted to post-menopause (0.22 QALYs and −USD6,276.73); and N0 restricted to high risk (0.20 QALYs and −USD6.335,99). The main impact drivers were chemotherapy costs, chemotherapy prescription probabilities, and acute myeloid leukemia incidence rate. The sensitivity analysis indicated a high probability of the test being cost effective.
Conclusions
The Oncotype DX test has a high likelihood of being a cost-effective strategy from the Brazilian private healthcare perspective. Alternative scenarios and test indications did not alter these conclusions.
Rituximab is a monoclonal antibody used to treat non-Hodgkin’s lymphoma. Since the expiration of the reference rituximab’s patent, several biosimilars have been marketed. As biosimilar products are not identical to reference medicines, synthesis of evidence comparing them is needed to understand their effects and harms.
Methods
We performed a Cochrane systematic review and searched main bibliographic (CENTRAL, MEDLINE, Embase, Web of Science) and clinical trials databases up to February 2024. We included head-to-head randomized controlled trials conducted in adults with lymphoma treated with rituximab biosimilar or reference. When possible, we pooled the results of the following outcomes using random-effects meta-analyses: progression-free survival, duration of response, overall survival, serious adverse events, objective response rate, and health-related quality of life. We used the revised Cochrane risk-of-bias tool to assess the risk of bias and GRADE to evaluate the certainty of evidence of critical and important outcomes.
Results
We included 16 studies (n=4,342 participants). The overall risk of bias was low. Rituximab biosimilar was likely similar to reference in progression-free survival, duration of response, and overall survival (moderate certainty evidence; data not pooled as survival estimates were adjusted for different factors or reported as rates); serious adverse events (risk ratio [RR] 1.03, 95% confidence interval [CI]: 0.94, 1.14]; 15 studies, n=4,197; moderate certainty evidence); objective response (RR 1.01, 95% CI: 0.98, 1.04; 15 studies, n=3,852; moderate certainty evidence); and mortality (RR 0.97, 95% CI: 0.70, 1.35; 8 studies, n=2,557; high certainty evidence). Imprecision was the main reason for downgrading certainty in the findings.
Conclusions
Treatment with rituximab biosimilars was likely similar to the reference in survival outcomes and rates of adverse events. The overall certainty of evidence was moderate.
Diabetes insipidus (DI) is a rare disease characterized by water balance disorders and is often associated with high morbidity. Incorporating new technologies into Brazil’s Unified Health System (SUS) requires technical rigor and public participation to ensure equitable health system. This study explored how public participation in developing a Clinical Protocol and Therapeutic Guideline (PCDT) could enhance equity and transparency in health policies.
Methods
To analyze the demographic characteristics and opinions of patients and stakeholders involved in the public consultation and to describe the transparency in handling these contributions. Contributions were collected during a 90-day open public consultation and analyzed in three stages: (i) reading all submissions; (ii) categorizing key ideas; and (iii) discussing implications. This methodology provided insights into public engagement and its influence on fairness and transparency in decision-making processes, highlighting the importance of inclusive approaches to health governance.
Results
A total of 15 contributions were received, with 86 percent originating from individuals, predominantly white women from southern Brazil aged 25 to 39 years. Participants rated the preliminary recommendations as very good (53%), good (40%), and average (7%). Although no suggestions were incorporated, all contributions were analyzed and responded to, with positive feedback on the protocol’s clarity. The contributions underscored the importance of a PCDT in the SUS for improving rare disease management and for fostering community engagement. The findings highlighted the need for broader knowledge dissemination to stimulate public participation and enhance diversity and inclusion across the country.
Conclusions
The public consultation for the PCDT on DI emphasized the importance of transparency and community engagement in health policies. While contributions praised the protocol’s clarity, findings revealed the need to expand outreach for greater inclusivity and regional diversity. Strengthening participation processes can enhance equity, improve rare disease management, and foster more responsive and inclusive health governance in Brazil.
Horizon scanning (HS) initiatives in Brazil began in 2008. Since then, the implementation of a national HS system has shown great evolution and expansion, especially after the creation of the National Committee for Health Technology Incorporation (CONITEC), which absorbed it in 2011. This work aimed to present Brazil’s National Horizon Scanning System, conducted by CONITEC, and its most recent results.
Methods
We developed an experience report, using mixed methods, with a descriptive analysis of HS activities conducted nationally and quantification of documents produced between December 2023 and November 2024 by CONITEC.
Results
HS reports developed by CONITEC currently support the decision-making processes regarding the: (i) incorporation of technologies into the public health system (90 reports); (ii) granting of new or emerging technologies by court order (five alerts); (iii) prioritization of topics for the elaboration or update of national clinical practice guides (28 topics); (iv) national preparation in case of public health emergencies (e.g., COVID-19 and mpox) (two documents); (v) innovation and national development (five brief syntheses); and (vi) financing of research with health technologies (one document).
Conclusions
The implementation of a national HS system in Brazil has evolved significantly and today it represents an important source of evidence that supports strategic decisions for Brazil’s public health system. From December 2023 to November 2024, CONITEC produced 131 HS studies to support decision-making in six different processes within the public health system.
HIV/AIDS continues to pose a significant public health challenge in Chile, despite advances in prevention and treatment. The Explicit Health Guarantees (GES) framework provides comprehensive access to antiretroviral therapy (ART) for eligible patients. This study assessed the budget impact of including bictegravir/emtricitabine/tenofovir alafenamide (BET) in first-line ART regimens for treatment-naïve adults under the Ministry of Health methodology for the GES program, evaluating its clinical benefits and financial viability.
Methods
A budget impact model was developed from the perspective of the GES system, utilizing updated public data on ART costs, therapy utilization, and demographic projections for 2025 to 2027. The analysis incorporated updated ART prices, therapy utilization frequencies, and clinical efficacy evidence. BET was evaluated as an alternative to abacavir/dolutegravir/lamivudine (ADL) using comparative evidence from clinical studies. Three scenarios were modeled: current prices, adjusted usage frequencies, and inclusion of BET in the treatment framework.
Results
The inclusion of BET had no significant budget impact, primarily due to cost-saving efficiencies from centralized procurement by the National Health Supply Center. Updated ART prices for 2023 indicated a 34.7 percent reduction compared with the 2022 Verification of Costs Study. Projected costs for GES HIV/AIDS management, including BET, were USD259 million (2025), USD284 million (2026), and USD312 million (2027). Therapy uptake and procurement efficiencies were the primary cost drivers. The addition of BET enhanced therapeutic options without imposing additional financial burden.
Conclusions
The integration of BET into first-line ART regimens aligns with the GES goals of financial sustainability and clinical efficacy, offering an effective alternative for HIV management. These findings underscore the importance of evidence-based policymaking and optimized resource allocation to improve healthcare outcomes in Chile.
For the first time, worldwide digital health applications (DiGA) have been reimbursed by the German Statutory Health Insurance. For full reimbursement, the manufacturers must provide scientific evidence based on efficacy studies. This study aimed to assess the methodological quality of efficacy studies for permanently listed and reimbursed DiGA in the categories of ‘nervous system’ and ‘psyche’ within the DiGA register.
Methods
DiGA in the categories of “nervous system” and “psyche” were selected from the governmental DIGA platform. The methodological quality of the studies was assessed using the revised Cochrane risk-of-bias tool for randomized trials. The risk of bias was assessed for the primary endpoint of each study according to an intention-to-treat analysis.
Results
Six DiGA were assessed for their methodological quality. Randomized controlled trials were conducted for all six DiGA that showed a high risk of bias, which was mainly due to a lack of blinding in the studies. In addition, dropouts were significantly higher in the intervention group than in the control group in most studies. For most of the DiGA, no published study protocol was available in advance, so an analysis of potential selective choice of the evaluation methodology was not possible.
Conclusions
The results revealed the low quality of supporting evidence for DiGA recently introduced in Germany, mainly due to methodological flaws, that is, a high potential for bias. Studies of DiGA should be blinded by comparing DiGA with a sham application to reduce the risk of bias. It should be emphasized that manufacturers submitted randomized controlled trials to prove the medical benefit of the DiGA investigated.
Access to gender reassignment surgery (GRS) as an isolated process would not imply achieving clinical and satisfaction results in transgender people. Public subsystems face a shortage of trained professionals, a lack of protocols, fragmented care, and economic and geographic barriers. This review sought evidence on integrated and equitable care models for access to GRS.
Methods
A systematic review (SR) was conducted on the effectiveness and safety of GRS prevalent in Argentina (vulvovaginoplasty [VVP] and mastectomy [MRP]) in transgender people older than 16 years. The SR also considered final perceptions from an integrated and comprehensive management approach. The Web of Science and MEDLINE databases were consulted, prioritizing clinical trials, SRs, health technology assessments, and relevant individual studies from 1988 to 2024, using a rapid umbrella review methodology. The results of the evidence were ordered by relevant outcomes (aesthetic, satisfaction, complications, mental health) within the framework of integrated models applicable to inclusive and equitable health policies.
Results
For MRP, six SRs (two specific, four general) and six cohort studies (three specific, three general) were included. For VVP, 16 SRs (nine specific, seven general) and 38 cohort studies (35 specific, three general) were included. Techniques for each surgery were described, citing results about complications (71%), quality of life (48%), mental health (16%), aesthetic aspects (58%), and satisfaction (73%), but only 0.2 percent considered them within frameworks of integrated models. With a lack of quality evidence, challenges persist in unifying classifications of outcomes over time and generalizing findings to different health systems.
Conclusions
The recommendations of scientific societies and current legal frameworks suggest access to GRS as an advanced step within comprehensive care processes for transgender people. The evidence showed a divergence between this approach and the findings, with data on complications and satisfaction predominating, less information on associated quality of life and mental health, and few references to integrated models.
Equity is a pivotal element in health technology assessment (HTA) to ensure fair and proportional access to healthcare needs and to mitigate health disparities. The incorporation of equity-oriented prioritization criteria into the development of clinical practice guidelines (CPGs) promotes social justice in health. This study systematically mapped equity-related criteria used to prioritize topics for CPGs.
Methods
A comprehensive scoping review was conducted in accordance with the Joanna Briggs Institute’ Manual for Evidence Synthesis and the PRISMA Extension for Scoping Reviews. The review protocol was pre-registered on the Open Science Framework. The review encompassed both peer-reviewed publications and gray literature published from 2000 onwards, without language limitations, that addressed topic prioritization criteria for CPG development. From an initial list of 22,675 records, 25 studies met the inclusion criteria. The extracted prioritization criteria were categorized into six domains and further refined into 20 distinct criterion.
Results
Of the included studies, 48 percent mentioned the criterion “equity relevance”, within the domain of “factors related to the health condition”, and/or “impact on equity/access” within the domain of “potential impact of the intervention”. These criteria were variably characterized, encompassing aspects such as “frequency of inequality-related issues in specific population groups (e.g., children under five years old)”, “inequities in access and specific needs of vulnerable groups”, “potential of the recommendation to reduce or increase health disparities”, “impact on patient autonomy and independence,” and “user perceptions of the CPG.”
Conclusions
Evaluating equity considerations related to a disease or health condition and the potential of a CPG to mitigate disparities are imperative in the topic prioritization process. Incorporating this approach can optimize resource allocation, enhance care for marginalized groups, promote social justice, reduce health disparities, and foster social cohesion, thereby contributing to public health and societal well-being.
Assessing health-related quality of life (HRQoL), quality of life (QoL), and well-being (WB) are essential for measuring health outcomes. This study provided a conceptual mapping of these measures, proposed evidence-based frameworks, and linked them to widely used generic patient-reported outcome measures.
Methods
A systematic literature review was conducted that included articles from databases and gray literature through to December 2023. Studies describing HRQoL, QoL, and WB concepts with their dimensions or domains were included, focusing on general population studies without design restrictions. Domains, subdomains, and facets were extracted and analyzed based on frequency and qualitative methods. These frameworks were then mapped to commonly used generic patient-reported outcome measures.
Results
From 14,114 papers, 35 studies and 36 frameworks were included (HRQol=15, Qol=5, WB=16). A total of 168 first, 225 second, and 79 third-level domains were retrieved and curated into 118 unique entities: HRQoL had 82 dimensions, QoL had 49, and WB had 69. Overlap analysis revealed 26 shared dimensions, with 26 unique to WB, 29 to HRQoL, and seven to QoL. Final models included 18 HRQoL, 22 QoL (18 from HRQoL plus 4), and 10 WB dimensions. Mapping of patient-reported outcome measures showed coverage for HRQoL of 59.4 percent, QoL of 65.9 percent, and WB of 34 percent. The EuroQol Health and Wellbeing instrument had the broadest coverage for HRQoL (17/18) and WB (5/10).
Conclusions
Significant inconsistencies and overlaps exist among definitions and domains for HRQoL, QoL, and WB. The lack of clear conceptual and operational definitions hinders the validity of measurement tools. This study underscored the need for clearer definitions and provided an initial step toward better understanding and measurement of these essential health and policy concepts.
National healthcare systems face challenges, including rising costs, aging populations, and increasing rates of chronic diseases, especially in rural and underserved areas. Decentralized care (DC) offers healthcare services in less complex settings, reducing travel, optimizing resource use, and enhancing patient centricity. This study explored DC initiatives, implementation strategies, challenges, and outcomes in four countries to establish a scalable framework.
Methods
Four countries with strong policies and initiatives supporting decentralized care were selected (Belgium, the Netherlands, Singapore, the UK) to understand how governments can enhance clinical outcomes, optimize costs, and improve patient satisfaction through DC models. Data collection involved a review of government documents and reports, complemented by interviews with senior stakeholders from hospital systems and government bodies. The analysis focused on understanding the principles and practice of DC in these countries.
Results
Significant progress was observed in these countries. The UK’s integrated care providers achieved a 12 percent reduction in hospital admissions, while Singapore’s MIC@Home saved 7,000 bed days and increased telemedicine usage by 40 percent. The Netherlands’ Better@Home saved EUR2 million annually and increased remote care by 20 percent. Belgium’s model reduced heart failure readmissions by 15 percent and improved rural access and appointment satisfaction by seven percent. A common framework emerged, structured around four central pillars: robust policies and regulations, advanced technology and data integration, development of infrastructure and community care, and comprehensive training for healthcare professionals.
Conclusions
DC is a pivotal and transformative approach that can enhance patient care and ensure sustainability of health systems, despite implementation complexities. Success hinges on robust policies, technological infrastructure, data integration, and adaptive training mechanisms. These benchmarks underscore the importance of collaboration among multiple stakeholders to implement DC, in order to sustainably meet the evolving demands and provide patient-centered care.